Sheaths for medical devices

ABSTRACT

A device is disclosed for therapeutic and/or diagnostic use in or on a patient&#39;s body. The device can have a sheath and a tool. The sheath can be made, at least in part, from a laminate. The laminate can have reinforcement fibers in longitudinal, latitudinal, helical, and/or other configurations around the sheath. The tool can be at least partially within the sheath. The tool can be attached to the sheath at one or more lengths along the tool. The sheath can be removed from the tool and replaced.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.12/537,166, filed 6 Aug. 2009, which is a continuation in-part of U.S.patent application Ser. No. 12/512,878, filed 30 Jul. 2009, which is acontinuation of PCT Application No. US2008/052535, filed 30 Jan. 2008,which claims priority to U.S. Provisional Application Nos. 60/887,319,filed 30 Jan. 2007; 60/887,323, filed 30 Jan. 2007; and 60/949,219,filed 11 Jul. 2007; and is a continuation-in-part of U.S. patentapplication Ser. No. 12/512,809, filed 30 Jul. 2009, which is acontinuation of PCT Application No. US2008/052542, which claims priorityto U.S. Provisional Application Nos. 60/887,319, filed 30 Jan. 2007;60/887,323, filed 30 Jan. 2007; and 60/949,219, filed 11 Jul. 2007; andis a continuation of PCT Application No. U.S.09/41637, filed 24 Apr.2009, which claims priority to U.S. Provisional Application No.61/125,720, filed 27 Apr. 2008; and is a continuation-in-part of U.S.application Ser. No. 12/477,005, filed 2 Jun. 2009, which claimspriority to U.S. Provisional Application Nos. 61/057,986, filed 2 Jun.2008; 61/086,739, filed 6 Aug. 2008; 61/105,385, filed 14 Oct. 2008, and61/205,866, filed 22 Jan. 2009; and is a continuation-in-part of U.S.application Ser. No. 12/477,048, filed 2 Jun. 2009, which claimspriority to U.S. Provisional Application Nos. 61/057,986, filed 2 Jun.2008; 61/086,739. filed 6 Aug. 2008; 61/105,385, filed 14 Oct. 2008, and61/205,866, filed 22 Jan. 2009; and claims priority to 61/086,739, allof which are incorporated by reference herein in their entireties.

BACKGROUND

1. Field of the Invention

This invention relates to the design and manufacture of high performancesheaths for use in medicine and other applications. These sheaths may beplaced over devices intended for the exploration and modification ofluminal cavities. The devices may be medical devices used to explore andmodify the body.

2. Description of the Related Art

Devices used to explore and modify luminal cavities may becomecontaminated by their surroundings. A medical device used in the bodymay become contaminated with material from the patient's body. Themedical device may be disposed of after use in a single patient.Alternately, the medical device may be cleaned after each procedure.

Alternately, the medical device may be covered, or partially covered,with a sheath that protects, or partially protects, the medical devicefrom contamination. This sheath may then be disposed of after eachprocedure. This sheath may be an integral or permanent part of themedical device. The medical device may need some or no cleaning.

Current sheaths are generally simple, homogenous polymer structures.Because they are made from a single material, they may represent acompromise between all the competing engineering requirements thatsheath may have. In many applications, these compromises harm theefficacy, cost, or efficiency of the medical procedure in which themedical device is being used. What is needed is a sheath that can beconstructed in such a way as to selectively incorporate whateverproperties are required for the application.

SUMMARY

A device is disclosed for therapeutic and/or diagnostic use in or on apatient's body. The device can have a sheath and a tool. The sheath canhave a laminate. The laminate can have reinforcement fibers. The sheathcan have a sheath length measured from a distal end of sheath to aproximal end of the sheath. The tool can be at least partially withinthe sheath. The tool can be attached to the sheath.

The tool can have a first proximal position and a second distalposition. The sheath length when the tool is in the first proximalposition can be substantially equal to the sheath length when the toolis in the second distal position.

The sheath can have a reinforcement member. The reinforcement member canbe more rigid than the laminate. The reinforcement member can besubstantially helical. The reinforcement member can be plastic, metal,any other material disclosed herein, or combinations thereof.

The tool can be releasably attached to the sheath.

The device can have a robotic system for therapeutic and/or diagnosticuse. The tool can be part of or attached to the robotic system. Thesheath can have a fluid tight seal to the tool.

A further device for therapeutic and/or diagnostic use in or on apatient's body is disclosed. The device can have a sheath and a tool.The sheath can have a laminate having reinforcement fibers. The tool canbe at least partially within the sheath. The tool can be fixedlyattached to the sheath.

The tool can have a sheathed tool length measured along the length oftool within the sheath. The tool can have a first proximal position anda second distal position. The sheathed tool length in the first proximalposition can be less than about 10% different (i.e., more or less) thanthe sheathed tool length in the second distal position.

A method is described for using a tool in or on a patient's body. Themethod can include attaching a distal end of a fiber-reinforced firstsheath to a tool. The tool can be radially within the fiber-reinforcedfirst sheath. The method can include sealing the first sheath to thetool. The sealing can include sealing the distal end of the first sheathto the tool. The method can include deploying the tool to a target sitein or on a patient's body for therapy and/or diagnostic use. Deployingthe tool can include controlling a robotic system to move the tool.

The method can include detaching the first sheath from the tool. Themethod can also include attaching a second sheath to the tool while thefirst sheath is attached to the tool or after the first sheath isdetached and/or removed from the tool.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 illustrates a variation of the device.

FIG. 2 illustrates a variation of the device.

FIGS. 3A through 3C are variations of cross-section A-A of FIG. 1.

FIG. 4A illustrates a variation of the device.

FIGS. 4B through 4D are variations of cross-section B-B of FIG. 4A.

FIG. 5 illustrates a variation of the device.

FIG. 6 illustrates a variation of the device.

FIG. 7 illustrates a variation of the device.

FIGS. 8 and 9 are variations of cross-section C-C of FIG. 7.

FIG. 10 illustrates a variation of the device.

FIG. 11A is a variation of cross-section D-D of FIG. 10.

FIG. 11B is a close up view of circle E-E of FIG. 11A.

FIGS. 12A through 12G illustrate variations of a seal.

FIGS. 13A through 13C are cross-sectional views of a length ofvariations of the device.

FIG. 14A illustrates a variation of the device.

FIG. 14B illustrates a variation of cross section H-H.

FIG. 14C illustrates a variation of cross section J-J.

FIGS. 15A through 150 are sectional views through variations of crosssection K-K of FIG. 1.

FIGS. 16 through 18 are tables listing film materials, reinforcementmaterials, and adhesive and matrix materials, respectively.

FIG. 19 illustrates a portion of a method that may be used to produceunidirectional fiber tape.

FIG. 20 illustrates a portion of a method that may be used to produceunidirectional fiber tape.

FIGS. 21 through 24 illustrate variations of arrangements ofunidirectional fiber tape.

FIG. 25 illustrates a variation of a method for making a laminate.

FIG. 26 is a graph illustrating a variation of temperature and pressureversus time graph for a method for compacting or curing or melting thatcan be used with a fiber tape.

FIG. 27 is a process flow chart of a variation of a process for making alaminate.

FIGS. 28A through 28H illustrate a method of making fiber tape.

FIGS. 29 through 32A illustrate a variation of a method formanufacturing the device.

FIG. 32B illustrates a closeup of circle N-N of FIG. 32A.

FIGS. 33A through 33G illustrate a variation of a method formanufacturing the device.

FIG. 34 illustrates a variation of a method for applying fiber to asheath.

FIG. 35 illustrates a variation of a method for curing or compacting asheath.

FIGS. 36 and 37 illustrate a variation of a medical device.

FIG. 38A illustrates a variation of a method of using the device with amedical device.

FIG. 38B illustrates a variation of a cross section Q-Q of FIG. 38A.

FIG. 38C illustrates a variation of a closeup S-S of FIG. 38B.

FIG. 38D illustrates a variation of a closeup R-R of FIG. 38B.

FIG. 38E illustrates a variation of the cross section shown in FIG. 38Bin which the articulating section of the medical device is bent at about90 degrees.

FIGS. 39A and 39B illustrate a variation of a method of using avariation of the device in the body.

FIGS. 40A and 40B illustrate a variation of the device.

FIG. 40C illustrates a variation of a method for placing a variation ofa device onto a medical device.

FIG. 41A illustrates a variation of the device attached to a medicaldevice.

FIG. 41B illustrates a variation of the device attached to a medicaldevice which is articulated into 90 degree bend.

FIG. 42 illustrates a variation of the device attached proximal to thearticulating section of a medical device.

FIGS. 43, 44A and 44B illustrate a variation of a method for attachingthe device to a medical device.

FIG. 44C illustrates a variation of a cross-section view T-T of FIG.44B.

DETAILED DESCRIPTION

FIG. 1 shows a sheath 400. The sheath may have or be one or more tubes402. Tube 402 may have a seam 404 running down the long axis of the tube402. The wall of tube 402 may be substantially leak-tight orfluid-tight. Tube 402 may have an open proximal end 406 and/or an opendistal end 408. Proximal end 406 may be closed. Distal end 408 may beclosed. Tube 402 may have a substantially constant diameter 410 andlongitudinal length 412. Longitudinal sheath length 412 can be measuredalong the of the longitudinal axis of the sheath wherein thelongitudinal axis follows the centerline of the sheath at all pointsDiameter 410 can be from about 0.1 inches to about 4 inches.Longitudinal sheath length 412 can be from about 2 inches to about 10feet.

FIG. 2 shows a variation of sheath 400. Seam 404 can form a spiralconfiguration on the outer surface of tube 402. The tube 402 can have aflat ribbon of material that is helically wrapped and sealed at the seam404.

FIGS. 3A, 3B and 3C show variations of a cross section of sheath 400taken at line A-A. FIG. 3A illustrates that the tube 402 can have acircular cross section. FIG. 3B illustrates that the tube 402 can havean elliptical cross section. FIG. 3C illustrates that the tube 402 canhave a square or rectangular cross section.

The tube 402 may have a tube wall 401 and a wall thickness 403. The wallthickness 403 can be less than about 25 μm (0.98 mil). The wallthickness 403 can be from about 25 μm (0.98 mil) to about 500 μm (18.6mil), more narrowly from about 50 μm (2 mil) to about 300 μm (11.8 mil),for example about 75 μm (3.0 mil) or about 100 μm (4 mil).

Tube wall 401 and tube 402 may be highly flexible, foldable articles.Tube wall 401 may have a high strength. For example, the tube wall 401may have an ultimate strength of greater than about 138 MPa (20 Ksi),more narrowly greater than about 276 MPA (40 Ksi), yet more narrowlygreater than about 414 MPa (60 Ksi).

The sheath 400 can have an unsupported burst pressure. The unsupportedburst pressure is the pressure at which the sheath 400 ruptures wheninflated in free air without any external constraint on the walls atabout 1 ATM external pressure and about 20° C. temperature. If theproximal end 406 is open, this end must first be capped to run thistest. If the distal end 408 is open, this end must first be capped to nmthis test. The unsupported burst pressure can be greater than about 150psi. For example, the unsupported burst pressure can be from about 1,400kPa (200 psi) to about 10,000 MPa (1,500 psi). More narrowly, the burstpressure can be from about 3,500 kPa (500 psi) to about 6,000 kPa (900psi). For example, the burst pressure can be about 3,500 kPa (500 psi),about 5,200 kPa (750 psi), about 7,000 (1,000 psi), about 10,000 kPa(1,500 psi), or higher than 10,000 kPa (1500 psi).

The sheath 400 can be non-compliant or inelastic. The sheath 400 canhave a failure strain of less than 0.30, more narrowly less than 0.20,more narrowly less than 0.10, yet more narrowly less than 0.05. Anon-compliant sheath can have a failure strain of less than 0.30.

The failure strain of the sheath is the difference between the balloonouter diameter 410 when the balloon is inflated to 100% of the burstpressure and the balloon outer diameter when the balloon is inflated to5% of the burst pressure (i.e., to expand from a deflated state withoutstretching the wall material) divided by the 100% pressure diameter.

For example, the burst pressure of the sheath 400 can be greater thanabout 3,500 kPa (500 psi) and have an outer diameter of about 17 mm anda wall thickness of less than about 100 μm with a failure strain of lessthan about 0.10, for example less than about 0.05.

The reinforced tube wall 401 may have a high tear strength as comparedto traditional polymers. Tear strength can correlate to puncturestrength and toughness. For example, in a Mod Mil-C-21189 10.2.4 teartest, a specimen is created. That specimen has a width, a height, andthickness. A slit is made in the sample parallel to the width, mid-wayalong its height. The slit is then pulled to initiate tear at thecorners of the slit. The Mod Mil-C-21189 10.2.4 tear test givesresultant data in tensile pounds force (lbf). For the test to bemeaningful as a comparison between two material samples, it should bedone on a thickness-comparable basis. A nylon 12 sheath material atabout 0.0055 in. thickness failed the test at a mean tensile load of 25lbf. The sheath wall of about 0.005 in. failed at a mean tensile valueof 134 lbf.

In an ASTM D-3039 tensile test, a nylon 12 material at 0.0055 in.thickness, failed at a mean tensile load of 22 lbf. The sheath wall ofabout 0.005 in. thickness can have a mean tensile failure value of about222 lbf.

The sheath 400 may have a high dielectric strength. For instance, it mayhave a dielectric strength greater than 1000 volts per mil (i.e., 0.001in.), for example greater than 2500 volts per mil, also for examplegreater than 5000 volts per mil.

The sheath 400 can be made from a material that can be resistant tochemicals, for example on the outside surface of the sheath 400. Forinstance, a material may be chosen that is resistant to bone cement(e.g., methyl methacrylate or polymethyl methacrylate).

FIG. 4A shows a variation of sheath 400 with a tube 402 and areinforcement member 414. The reinforcement member 414 may form aspiral. The reinforcement member 414 may be attached to the tube 402.The reinforcement member 414 may be a helical spring. The reinforcementmember 414 can be more rigid than the laminate of the wall of the tube.The reinforcement member 414 can be made from a plastic, metal, anymaterial described herein, or combinations thereof.

FIGS. 4B, 4C and 40 show several possible cross sectional variations ofthe reinforcement member 414.

FIG. 4B shows a rectangular cross section of reinforcement member 414with width 418 and height 416. FIG. 4B shows the reinforcement member414 attached to the outer wall of tube 402.

FIG. 4C shows a circular cross section of reinforcement member 414 withwidth 418 and height 416. FIG. 4C shows the reinforcement member 414placed between tube 402A and tube 40213.

FIG. 4D shows an elliptical cross section of reinforcement member 414with width 418 and height 416. FIG. 4D shows the reinforcement member414 attached to the inner wall of tube 402.

Width 418 can be from about 0.001 in. to about 0.100 in., more narrowlyfrom about 0.010 in. to about 0.040 in. Height 416 can be from about0.0005 in. to about 0.050 in., more narrowly from about 0.002 in. toabout 0.010 in.

FIG. 5 shows a variation of sheath 400 with tube 402. Tube 402 may havea first diameter 410 a at the proximal tube end 406 and a seconddiameter 410B at the distal tube end 408. First diameter 410 a may belarger than second diameter 410 h. The tube diameter may smoothly taperbetween the proximal and distal ends of the tube 402.

FIG. 6 shows a variation of sheath 400 with tube 402. Tube 402 may havea first diameter 410 a, a second diameter 410 b, a third diameter 410 cand a fourth diameter 410D. The diameters can smoothly vary along thelength of the tube.

FIG. 7 shows a variation of sheath 400 with tube 402 and seam 404.Sheath 400 may have a proximal seal 420 a and distal seal 420B.

FIG. 8 shows a variation of a cross sectional view of FIG. 7. Sheath 400is shown with a single tube 402.

FIG. 9 shows a variation of a cross sectional view of FIG. 7. Sheath 400is shown with a tube 402 a and tube 402 h. Tube 402 a is inside of tube402 b.

FIG. 10 shows a variation of sheath 400. FIG. 11A shows a cross sectionof FIG. 10. FIG. 11B shows a magnified view of a portion of FIG. 11A.The distal end 408 of sheath 400 may have an endcap 422. Endcap 422 maybe located within the inside diameter of tube 402. Endcap 422 may fitover the distal end of a medical device. Endcap 422 may be a clearwindow. Endcap 422 may make an airtight, circumferential attachment totube 402. Endcap 422 may contain an adhesive seal, a heat seal, anexternal band seal or combinations thereof. Endcap 422 may attach to amedical device. The proximal end 406 of the sheath may have a seal 420.

FIG. 12 a illustrates a seal 420 having a substantially circularcross-section. FIG. 12 b illustrates a seal 420 having a substantiallyx-shaped cross-section. The seal in FIG. 12 b can have four seal arms424 extending therefrom. FIG. 12 c illustrates a seal 420 having asubstantially C-shaped cross-section. The seal in FIG. 12 c can have twoseal arms 424 extending therefrom. FIG. 12 d illustrates that seal 420can be a cup seal. Cup seals can have cantilevered sealing surfaces,which can be lower drag and more compliant against irregular surfacesthan a-ring (compression) seals. FIG. 12 e illustrates that the seal 420can have one or more separate seal heads 426 each with a single seal armextending from the seal head 426. All of the seal arms 424 can all beunidirectional. FIG. 12 f illustrates that the seal 420 can have anumber of unidirectional seal arms 420 extending from a single backing428. FIG. 12 g illustrates that the seal 420 can have a seal spring 429inserted into the seal 420 to pressurize the cantilever arms 420outward.

The seal durometer, material surface friction, squeeze pressure, size,pressure area, and combinations thereof can be varied to modulatedesired seal drag. Seal materials can be low durometer to be morecompliant and seal with lower forces and lower drag. The seals 420 canhave in-seal lubricants. Fluid lubrication can be applied to the seal420. The seal 420 can have a geometry that limits directional variation,such as a cup seal. Lubricants or other low friction elements can beadded. The seal may be compliant or substantially non-compliant.

FIG. 13A, FIG. 13B and FIG. 13 c show cross sections of a tube wall 401.FIG. 13A illustrates that a tube 402 can have a constant or varying wallthicknesses 46 along the length of the tube 402. A wall first diameterthickness 46 a can be substantially equal to a wall second diametersection thickness 46 c and the wall taper thickness 46 b.

FIG. 13B illustrates that the wall second diameter section thickness 46c can be substantially greater than the wall first diameter thickness 46a. The wall taper thickness 46 b can be less than the wall seconddiameter section thickness 46 c and greater than the wall first diameterthickness 46 a.

FIG. 13C illustrates that the wall second diameter section thickness 46c can be substantially less than the wall first diameter thickness 46 a.The wall taper thickness 46 b can be greater than the wall seconddiameter section thickness 46 c and less than the wall first diameterthickness 46 a.

FIG. 14A shows a tube 402 with seam 404.

FIG. 14B shows a cross section taken at H-H. Wall 401 may contain innerlayer 74 and outer layer 76.

FIG. 14C shows a cross section taken at J-J. Wall 401 may contain innerlayer 74, layer 72 and outer layer 76.

Any of the layers 72 can be a laminate of fiber and resin. Any of thelayers 72 can be a polymer film. Layers may continue across the seam 401or end at the seam 401. Any combination of the layers can be leak-proof,reinforced with one or more fibers, resistant and releasable from MMA,or combinations thereof. For example, the first layer can be leak-proofand form the bladder. The second layer can be reinforced with a fiber.The third layer can be MMA-resistant and/or MMA-releasing.

FIG. 15A illustrates that the balloon wall 401 at section K-K or atother sections taken through a single wall of the balloon can have alayer 72 that can have a fiber tape matrix. The fiber tape matrix canhave one or more reinforcement fibers 86 and one or more resins. Theresin can be a flexible adhesive 208. The flexible adhesive can remainflexible when cured or melted to form the sheath 400.

The fiber tape (also referred to as unidirectional fiber reinforcedtape, unidirectional tape, and uni-tape) may have one, two or moremonofilaments 86 running substantially parallel to each other andembedded in a flexible adhesive 208. Uni-tape may be produced with aremovable backing. The removable backing can be made of paper, plastic,film, metal, elastomer, foam, fabric or combinations thereof. Thesubstantially parallel mono filaments may be positioned within theflexible adhesive such that they are touching each other along theirlength. The substantially parallel monofilaments may be positioned suchthat there is flexible adhesive separating each fiber along its length.

FIG. 15A illustrates fiber array layer 72 having a layer width 210 incross-section. The layer width 210 can include a number of fibers 86,for instance first fiber 86 a and second fiber 86 b. The layer 72 canhave a linear quantity fiber density measured, for example, as thenumber of fibers 86 per unit of layer width 210. The linear quantityfiber density can be equal to or greater than about 500 fibers per inch,more narrowly equal to or greater than about 1000 fibers per inch, morenarrowly equal to or greater than about 2000 fibers per inch, yet morenarrowly equal to or greater than about 4000 fibers per inch. Forexample, the liner quantity fiber density can be from about 1,000 fibersper inch to about 2,000 fibers per inch.

The fibers 86 or monofilaments can be high strength and inelastic. Thefibers can have a fiber or monofilament diameter 212, for example, fromabout 1 μm to about 50 μm, for example less than about 25 μm, morenarrowly less than about 15 μm. The unidirectional fiber-reinforced tapecan have the same or different sizes and materials of fibers within thesame unidirectional fiber-reinforced tape.

The fiber tape layer 72 can have a layer thickness 216 from about 1 μmto about 50 μm, more narrowly from about 8 μm to about 25 μm, yet morenarrowly from about 10 μm to about 20 μm.

FIG. 15B illustrates that the fiber density can be less than the fiberdensity shown in FIG. 15A. For example, the fiber density can be about500 fibers per inch.

FIG. 15C illustrates that the inner layer 72 b can have a fiber tapehaving reinforcement fibers 86 in an adhesive 208. The outer layer 72 acan have a polymer film. The laminate shown can be a part of or theentire wall 401. The internal volume of the sheath volume 24 can be onthe radial inside of the sheath.

FIG. 15D illustrates that the outer layer 72 a can be a fiber tape. Theinner layer 72 b can be a polymer film.

FIG. 15E illustrates that the outer layer 72 a and the inner layer 72 bcan be polymer films. In any variation, the polymer films can be thesame or different polymers, or any combination thereof. The first middlelayer 72 c can be a fiber tape.

FIG. 15F illustrates that the outer layer 72 a, inner layer 72 b, andsecond middle layer 72 d can be polymer films. The first middle layer 72c can be a fiber tape. Any adjacent layers, such as the third middlelayer 72 e and the outer layer 72 a can be joined with adhesive, bymelting, solvation, welding or combinations thereof.

FIG. 15G illustrates the outer layer 72 a, inner layer 72 b, firstmiddle layer 72 c and third middle layer 72 e can be polymer films. Thesecond middle layer 72 d can be a fiber tape.

FIG. 15H illustrates that the outer layer 72 a can be a first fibertape. The inner layer 72 b can be adjacent to the outer layer 72 a. Theinner layer 72 b can be a second fiber tape. The first and second fibertapes can be uni-tapes. The fiber in first fiber tape can form an anglewith the fiber in the second fiber tape. Part or all of the wall 401 canhave multiple fiber tape layers in a wall section area 131. The area 131can include a number of fibers.

Part or all of the wall 401 can have a volumetric quantitative densityof fiber measured, for example, as the number of fibers per unit ofarea. The area quantity fiber density can be equal to or greater thanabout 100,000 fibers per square inch, more narrowly equal to or greaterthan about 250,000 fibers per square inch, more narrowly equal to orgreater than about 1,000,000 fibers per square inch, yet more narrowlyequal to or greater than about 4,000,000 fibers per square inch. Thearea quantity of fiber can be about 25% of the area of a wall crosssection, more narrowly about 50%, more narrowly about 75%.

The ratio of the volume of the fiber tape to the volume of the fibers 86can be about equal to or greater than about 15%, more narrowly equal toor greater than about 30%, more narrowly equal to or greater than about50%, yet more narrowly equal to or greater than about 75%.

FIG. 151 illustrates that a wall 401 can be made by positioning, asshown by arrows, an inner layer 72 b having a first laminate 130 a onthe outer layer 72 a having a second laminate 130 b. The first laminate130 a can be consolidated to the second laminate 130 b. Consolidationcan include heating, pressurizing, solvating, or combinations thereof ofthe first laminate 130 a and the second laminate 130 b.

FIG. 15J illustrates that the outer layer 72 a, and inner layer 72 b canbe polymer films. The first middle layer 72 c and the second middlelayer 72 d can be fiber tapes.

FIG. 15K illustrates that the outer layer 72 a, inner layer 72 b, secondmiddle layer 72 d, and third middle layer 72 e can be polymer films. Thefirst middle layer 72 c and the fourth middle layer 72 f can be fibertape.

FIG. 15L illustrates that the wall 401 can be made by positioning, asshown by arrows, a first laminate 130 a on a second laminate 130 b. Thefirst laminate 130 a can be consolidated to the second laminate 130 b.The first laminate 130 a can have the outer layer fixed to the fourthmiddle layer, which can be fixed to the third middle layer. The secondlaminate 130 b can have the inner layer fixed to the first middle layer,which can be fixed to the second middle layer.

FIG. 15M illustrates that the outer layer 72 a, inner layer 72 b, secondmiddle layer 72 d, third middle layer 72 e, fifth middle layer 72 g, andsixth middle layer 72 h can be polymer films. The first middle layer 72c, fourth middle layer 72 f and seventh middle layer 72 i can be fibertapes.

FIG. 15N illustrates that the wall 401 can be made by joining, as shownby arrows, a first laminate 130 a, a second laminate 130 b, and a thirdlaminate 130 c.

FIG. 15O illustrates that the outer layer 72 a can be an MMA-resistantand MMA-releasing polymer film. The inner layer 72 b can be a leak proofbladder made from a polymer film. The first middle layer 72 c can be afiber tape, for example with the fibers oriented as longitudinal fibers.The second middle layer 72 d can be a resin or adhesive. The thirdmiddle layer 72 e can be a fiber tape, for example with the fibersoriented as latitudinal or hoop fibers. The fourth middle layer 72 f canbe a resin or adhesive. The fifth middle layer 72 g can be a radiopaquelayer, such as a metal foil or a radiopaque metal foil. The sixth middlelayer 72 h can be a resin or adhesive.

The radiopaque metal foil and any other radiopaque or metal elementherein can be made from gold, platinum, platinum-iridium alloy,tantalum, palladium, bismuth, barium, tungsten, or combinations thereof.Any of the layers can have particles of gold, platinum, platinum-iridiumalloy, tantalum, palladium, bismuth, barium, tungsten or combinationsthereof. Any of the layers can have radiopaque dyes.

The foil can be less than about 30 μm thick, for example less than about20 μm thick, for example about 15 μm, about 12 μm, about 10 μm or about8 μm thick. Radiopaque foils can be cut or patterned by laser cutting,wire EDM, die cutting or deposition. The foils may be mounted to aremovable backing before cutting such that a pattern of foils may beeasily applied during the balloon construction process.

The panel, such as a foil, can be located in the wall 401 in an areathat is exposed to increased stresses during inflation. A radiopaquefoil can strengthen the wall 401.

A metal film or foil layer on the outside of the balloon can also beused to resist chemical attack. This metal film or foil layer may givethe balloon radiopacity. The outer surface of the balloon may also havea coating that may help the balloon resist chemical attack. The coatingmay be flouropolymer based.

Any of the polymer or fiber tape layers can be leak proof, water tight,air tight, MMA-resistant, MMA-releasing, or combinations thereof.

Several laminates, each with different fiber orientations and adifferent number of layers, may be created. Alternately, a singlelaminate may be constructed with multiple fiber orientations and layerquantities placed into different regions of the larger laminate. Fromthis single laminate, smaller laminates with specific fiber orientationscan then be removed and used to create part or all of a tube.

If it is desired that the outside of the laminate be low friction andresistant to harm from chemicals, or that the laminate readily releasefrom certain adhesives (such as, for instance, Methyl methacrylate, aprincipal ingredient in bone cement), a fluoropolymer such as FEP(Fluorinated ethylene propylene) may be selected for the outer layer.One side of the FEP film can be treated via a plasma method or any othermethod for allowing routine adhesive bonds to flouropolymers. Thetreated layer can face into the adhesive matrix, such that it can form astrong bond, while the outer layer faces out and provides the desiredchemical and mechanical properties.

The materials that form a laminate may be modified by the addition ofcertain elements that give desired additional properties useful for tubewall 401 and tube 402.

Radiopacity may be a desired property in a sheath. Radiopacity may makethe sheath visible to the medical practitioner during a procedure. Forinstance, the radiopaque materials may cause the sheath to be visiblewith a fluoroscope.

Radiopaque materials may be added to the adhesive, the fiber or the filmused to create a laminate.

Radiopaque materials may be added to the adhesive that is used to createa fiber tape. For instance, particulate could be added to the adhesive.This particulate could be made out of aluminum, titanium, lead,tungsten, bisumuth, tantalum or combinations thereof, for example USAluminum Power, Part Nos. US254012 or US15212. The particulate can beadded to the adhesive with a homogenizer, an ultrasonic mixer, by usingshear dispersion, by using hydraulic dispersion or by other mixingtechnologies.

Radiopacity could also be added by mixing typical radiopaque dyes intothe adhesive. The added materials could mix with the adhesive or bedissolved in it.

The added material may co-react with the adhesive. For instance, thematerial may end up cross-linked with the base adhesive.

Radiopacity could also be added to the laminate by embedding materialsin the polymer film of the laminate. During the formation of the polymerfilm, materials such as those mentioned above could be dispersed, mixed,dissolved or cross-linked with the film.

A polymer film that is made part of a laminate could also be coated withone or more materials, such as a metal, that would give the filmradiopacity. A coating could be vapor deposited, sputter coated,solution coated, reverse roll coated, slot dye coated, air dye coated,gravure coated, spray coated, electrostaticly coated, ink jet printed orcoated in some other way known in the art. The purpose of applying thisfilm may also be to give the tube electrical conductivity for someclinical purpose.

The polymer film may also be printed with an antennae pattern of somekind. This would allow the tube to selectively absorb RF radiation. TheRF radiation could be used to drive a load in or on the tube, such as aheater or other device. The heater could be built out of carbon fiberwith resistivity fabricated such that it acts as a heating element forthe current produced by the antennae.

The fibers in the fiber tape may also serve to give the resultinglaminate radiopacity to X-rays. The fibers could be coated, using thesame methods as described for films. Particulate, dyes or othermaterials can be added during the formation of the fibers such that theyhave significant radiopacity.

Magnetic resonance visualization enhancement materials, such as magneticcontrast agents, can be added to the adhesive, the film or the fiber.The magnetic resonance visualization enhancement materials can enhancethe visualization of the balloon during a magnetic resonance imaging(MRI) procedure. For example, the magnetic resonance visualizationenhancement material can be gadolium, Omniscan, Optimark, ProHance,Magnevist, Multihance, or combinations thereof.

Any of the layers, for example the outer layer, can be tinted or dyed avisible spectrum color. For example, a pigment, coloring additive.dispersions or other coloring agents, such as a coloring additive fromPlasticolors (Ashtabula, Ohio) can be added to the adhesive, laminate orfiber before consolidation. A paint or coating can be added to a layersurface or to the outer surface of the balloon wall.

The color can be selected for branding, market differentiating, as anindication of the type of device, the size of the device, orcombinations thereof. For example, devices having a selected diameter,length, pressure rating, clinical indication or efficacy, other commonperformance metric, or combinations thereof, can be dyed a specificcolor (e.g., green for a first type of device, red for a second type ofdevice).

The layers can have one or more optical fibers. The fiber optic can be astrain sensor. The strain sensor can monitor the laminate's mechanicalstatus in real time. The fiber optic can guide light delivery into thebody. The fiber optic can visualize a target site (e.g., gather lightfrom the body to produce a visual image).

A strain gauge could also be added to the laminate during manufacture.This strain gauge could allow real time monitoring of the laminatemechanical status. The laminate could be used in the body as part of alarger structure such as a tube, or the laminate could be used byitself.

Reducing the transport of gas or liquid thru the laminate may be a goalof these additives. For example, Angstrom Materials's (Dayton, Ohio)nano-scaled grapheme platelet raw materials can be added to theadhesive. Other nano-materials may be added to the adhesive, film orfiber to improve such properties as adhesion, strength or stiffness.

The design of the laminates may give the laminate high strength or hightoughness or high flexibility or resistance to abrasion or resistance totearing (i.e., rip-stop) or resistance to extreme temperatures orresistance to dielectric breakdown or resistance to chemicals or forcombinations thereof or any other property that may be incidental to thematerials or construction and is appropriate to the application or forcombinations thereof.

FIG. 16 illustrates polymer films from which the layers can be made. Thethickness of the polymer films can be from about 2 μm to about 50 μm,more narrowly from about 2 μm to about 18 μm, yet more narrowly fromabout 4 μm to about 12 μm. These films may be chosen for their highstrength or high toughness or resistance to abrasion or resistance toextreme temperatures or resistance to dielectric breakdown or resistanceto chemicals or for combinations thereof or for any other property thatthey naturally have that is appropriate to the application or forcombinations thereof.

FIG. 17 illustrates materials from which the reinforcement fibers can bemade.

FIG. 18 illustrates that the adhesive can be an elastomeric thermosetmaterial, an elastomeric thermoplastic material, or a combinationthereof. The adhesive can be selected from any of the materials, orcombinations thereof, listed in FIG. 18. The matrix can have a resin anda fiber. The resin can be an adhesive.

Method of Making

FIG. 19 and FIG. 20 illustrate one method of uni-tape fabrication. Towsor bands 270 provide the extruded monofilaments or fibers 86 which areoptionally passed through a treatment bath 272 to improve adhesivebonding features of the exterior of the monofilaments via chemicaletching, plasma arc etching or corona discharge etching. The pretreatedmonofilaments from the tows are pulled through an adhesive bath 274 overand under first rollers 232 a where the matrix adhesive coats andsurrounds the mono filaments.

The adhesive-coated monofilaments are drawn through a fixed gap rotarydie 278. Release material 276 from second rollers 232 b can be appliedto the top and bottom of the adhesive coated monofilaments, for example,prior to the pulling of the tows 270 through the fixed gap rotary die278 which controls adhesive content and spreads the filaments. During apull-trusion process, the individual tows are laterally joined to form auni-tape which is heated by a heater 280 for viscosity change, afterwhich the tape is compacted via rolls third rollers 232 c. The compactedtape can then be passed over a chill plate 282 to the spool 244, withthe top sheet of release material being removed at roll fourth roller232 d and reeled up on fifth roller 232 e.

The monofilaments can be subject to less than about 0.02 pounds oftension during assembly substantially immediately before themonofilaments set in the adhesive matrix. For example, substantially notensioning can be applied to the monofilaments during manufacturingimmediately before the mono filaments set in the adhesive matrix.

Another kind of fiber tape (hereafter referred to as woven tape) mayhave a woven, knitted or braided fiber cloth, a flexible adhesive, andan optional removable backing or combinations thereof. The removablebacking can be made of paper, plastic, film, metal, elastomer, foam,fabric or combinations thereof.

Woven, knitted and braided cloths are known though modem textileproducts. Typically, weave patterns feature a warp threads, running in afirst direction, and weft threads, running in a second direction. Theangle between the first and second directions may be 90 degrees. Theangle between the first and second directions may be 75 degrees. Theangle between the first and second directions may be 60 degrees. Theangle between the first and second directions may be 45 degrees. Theangle between the first and second directions may be oriented at anyappropriate angle. In the process of weaving, the threads may beinterlaced in various ways to form weave patterns depending on theproperties desired.

Another kind of fiber tape (hereafter referred to as matted tape) canhave matted fiber, a flexible adhesive, and an optional removablebacking or combinations thereof. The removable backing can be made ofpaper, plastic, film, metal, elastomer, foam, fabric or combinationsthereof. The matted fiber may be a collection of randomly orientedfibers of different lengths.

FIG. 21 shows that layers 72 c and 72 d can have reinforcement fibers 86oriented in the same direction. This is a 0-0 arrangement, because ofthe angle that each layer 72 d makes with a vector aligned with thefibers of the bottom layer 72 e. This arrangement may provide twice thestrength in the fiber direction as the uni-directional tape itself.

FIG. 22 shows that layers 72 c and 72 d can have reinforcement fibers 86oriented perpendicular to each other. This is a 0-90 arrangement,because of the angle that the second layer 72 d makes with a vectoraligned with the fibers of the bottom layer 72 c. This arrangement mayprovide substantially the same strength in the 0 degree and 90 degreedirection as the uni-directional tape itself.

FIG. 23 shows that layers 72 c, 72 d and 72 e can have reinforcementfibers 86 oriented at 0-0-90 to each other. This arrangement may provideapproximately twice the strength in the 0 direction than a single layerof uni-tape provides. This arrangement may provide strength in the 90direction approximately equal to that of a single uni-tape.

FIG. 24 shows that layers 72 e, 72 d, 72 e, 72 f, 72 g, and 72 h can beoriented at 0,30,60,90,−30, −60 respectively to each other.

A laminate may include one or more fiber tapes. A laminate may includeone or more polymer films.

The one or more fiber tapes and, optionally, the one or more polymerfilms can be consolidated into a laminate. Consolidation may includecompaction and curing or melting. Compaction can occur before curing ormelting. Compaction may include the application of heat and/or lightand/or an electron beam, the application of force (i.e., pressure), andthe passage of time. Curing or melting may include the application ofheat or light, the application of force (i.e., pressure), and thepassage of time.

During the process of consolidation, fibers may shift position withinthe laminate. During the process of consolidation, the fibers may getcloser to each other within the laminate.

The polymer film or polymer films may melt during the consolidationprocess or the polymer films may not melt. The polymer films can be onone or both outer surfaces of the laminate and different materials canbe put on each side. The polymer film can be on only one side of thelaminate, or absent altogether.

The polymer film could be formed by applying a polymer in a wetapplication process, such as spraying, dipping, painting, orcombinations thereof.

The polymer film may be coated with a material. The coating may beapplied by, for instance. sputter coating. The material that is coatedon the polymer film may provide substantial radiopacity.

FIG. 25 shows an example of the fabrication of a laminate by using anauto clave. Various layers of fiber tape material 72 c, 72 d, and 72 ecan be between an outer layer 72 a of a film and an inner layer 72 b ofa film. The fiber tape material and the films can be between a topvacuum sheet 238 a and a bottom vacuum sheet. The bottom vacuum sheetcan be placed on a rigid plate or platen 288. Sealing is provided byseals 286. A breather material 284 may be between the outer layer 72 aand the top vacuum sheet 238 a, for example for evacuating gas frombetween the vacuum sheets. The enclosed volume or bag between the topand bottom vacuum sheets can be evacuated at the suction tube 242.

During the autoclave process as illustrated in FIG. 27, the processsteps are first to lay down the bottom vacuum sheet as illustrated at290. Secondly, one optionally lays down the inner layer 292 to belaminated or consolidated as illustrated at 292, followed by the peelingoff of the removable backing and laying down the first middle layer asillustrated at 294. Thereafter as illustrated at 296, optionaladditional middle layers can be laid down after removal of theirremovable backing. Additional fiber tape can be laid down in additionaldirections as needed. Thereafter, the outer layer can be optionally laiddown as illustrated at 298. A breather material 284 may be positionedbetween the outer layer and the top vacuum sheet. The top vacuum sheetcan be laid down over the breather material 284 as illustrated at 300.The structure can be placed in an autoclave as illustrated at 302. Thevolume between the bottom and top vacuum sheets can be evacuated aftersealing the edges as illustrated at 304.

Thereafter, as part of a consolidation phase, follows a compaction phaseas illustrated at 306 at the requisite pressures and temperatures.Thereafter, as part of a consolidation phase, follows a curing or meltphase as illustrated at 308 at associated pressures and temperatures.

One set of pressures and temperatures useful for a compaction or cure ormelt phase is illustrated in FIG. 26 by the temperature time graph andassociated temperature pressure graph.

Several laminates, each with different fiber orientations and adifferent number of layers, may be created. Alternately, a singlelaminate may be constructed with multiple fiber orientations and layerquantities placed into different regions of the larger laminate. Fromthis single laminate, smaller laminates with specific fiber orientationscan then be removed and used to create a medical inflatable.

The laminate can be made as describe in U.S. Pat. No. 5,333,568 or U.S.Pat. No. 5,470,632, both of which are herein incorporated by referencein their entireties.

A layer may be leak tight. The layer may be made by dip molding, forexample, urethane or nylon, over a mandrel. The layer may be made byrotational molding.

The layer may be made by coating a substance over a mandrel or a layer72. A coating may be, for instance, parylene. A coating may be a metal,such as gold. A coating may electrodeposited, electroless deposited orvia physical vapor deposition or a combination thereof. A coating mayhave significant radiopacity. A coating may increase the toughness ofthe balloon, or increase its lubricity. A coating may reduce oreliminate attack or adhesion from chemicals. For instance, a coating maycause the balloon to not be attacked or to adhere to bone cement.

A layer may be formed by conformal coating. A conformal coating mayinclude a flouropolymer. The coating may be dipped on, sprayed on orapplied by electrostatically charging the substrate or by combinationsthereof. Coatings may be cured by baking.

A layer may be formed by blow molding. The blow molding process caninclude a parison. The parison may be open at both ends, or only open atone end (i.e., a blind parison).

FIG. 28A illustrates that a layer of fiber tape can be made on a roller232. The roller can be configured to rotate about a roller axle 234. Theroller may have a diameter from about 100 mm to about 1,000 mm. Theroller may be made or coated with an anti-stick material such as aflouropolymer.

FIG. 28B illustrates that a releaser 236, such as a release layer, canbe placed around the circumference of the roller 232. The release layercan be a low friction film or coating. The release layer may be athin/flexible flouropolymer sheet.

FIG. 28C shows that an adhesive layer can be placed on the releaser ordirectly onto the roller (e.g., if no releaser is used). The adhesivelayer may be a thermoplastic film. The adhesive layer may be a thermosetadhesive. The adhesive layer may be a solvated thermoplastic orthermoset.

FIG. 28D shows the application of fiber to the roller. Fiber may beunwound from a spool (not shown) and rolled onto the top surface of theadhesive. The fiber may contain one or more monofilaments. The fiber mayhave been previously flattened as detailed in this application. Anycoating or sizing on the fiber may have been removed using a solvent.The fiber may be placed with a gap between each successive fiber wrap.The gap can be less than about 25 μm, more narrowly less than about 5μm.

FIG. 28E shows a reinforcement layer on top of the adhesive on top ofthe release layer.

FIG. 28F illustrates that the roller can be placed between a vacuum topsheet 238 a and a vacuum bottom sheet 238 b, for example in a vacuumbag. A vacuum seal tape 240 can surround the roller between the vacuumbottom and top sheets. The air can be removed from between the vacuumtop and bottom sheets and within the vacuum seal tape, for example bysuction from a suction tube 242. Inside and/or outside of the vacuumbag, the roller can be heated, for example to melt or cure the adhesive.

FIG. 28G shows the removal of the layer. For instance, a cut may be madesubstantially perpendicular to the fiber. The layer may be peeled awayfrom the release layer.

FIG. 28H illustrates that the layer of fiber tape can be removed fromthe roller. For example, the layer can be peeled off the releaser.

The layer can be cut into a pattern. For instance, the layer can be cutwith the trimming jig, a laser, a water jet cutter, a die cut tool, or acombination thereof.

FIG. 29 illustrates that part or all of the sheath 400 may beconstructed by forming one or more layers 72 into the tube wall 401and/or tube 402. The layer thickness 430 of layer 72 may be from about0.0005 in. to about 0.020 in.

FIG. 30 illustrates that a first layer 72 a may be attached to a secondlayer 72 b with an offset distance 434. First layer 72 a may be a fiberreinforced laminate. Second layer 72 b may be a polymer film (such asthat listed in FIG. 16) covering a portion of the side of the laminatethat will end up on the outside of the tube. Second layer 72 b mayextend beyond the edge of first layer 72 a. First layer 72 a may berolled such that layer edge 432 a is the first edge rolled and secondlayer edge 432 b is the last edge rolled. This may allow layer 72 b tooverlap itself on the outside of the resulting tube. Adhesive may beapplied in this overlap 438 (shown in FIG. 31) to form an outer layerfilm layer for the tube.

FIG. 31 shows first layer 72 a and second layer 72 b as a partiallyformed tube 436. The layers 72 can be rolled so as to form a smalloverlapping seam 438. The layers 72 may be rolled around a solid formsuch as a tubular mandrel (not shown). Adhesive may be placed inside theoverlapping seam 438. If the laminate is not consolidated, adhesive inoverlapping seam 438 may be omitted.

Referring now to FIGS. 32A and 32B, first layer 728 and second layer 72b may be rolled so that the sheet goes around substantially more thantwice to make a partially formed tube 436. Layers 72 may be rolledexactly twice to form a tube 436. Layers 72 may be rolled around threetimes or substantially more than three times to form a tube 436. Layer72 b may be substantially wider than layer 72 a such that, when a tubeis formed, layer 72 b wraps around about 2 times and layer 72 a wrapsslightly more than one time.

FIGS. 33A to 330 show a method of making a tube 402. A sheath 400 can bea single tube 402 or multiple tubes 402. FIG. 33A shows an inflatablemandrel 440. The mandrel can be inflated through a closeable inflationport 442. The mandrel 440 may be a thin walled soft structure made outof, for instance, silicon or some other elastomer.

FIG. 33B shows inflatable mandrel 440 with thin walled tube 444 placedover it. Thin walled tube 444 may be one of the materials shown in FIG.16.

FIG. 33C shows layer 72 being wound over thin walled tube 444 in aspiral fashion. Each spiral may overlap with the previous tum, thusallowing layer 72 to mostly or completely cover thin walled tube 444.

FIG. 33D shows the process after the spiral wind of layer 72 iscomplete. Optional additional layers may be applied at this point (notshown). An additional layer may be a film.

FIG. 33E shows the inflatable mandrel 440, the thin walled tube 444 andthe layer 72 being placed into a cavity mold. The top of the mold 446 isshown aligned with the bottom half of the mold 448.

FIG. 33F shows the top of the mold 446 closed on the bottom of the mold448 and enclosing the inflatable mandrel 440, the thin walled tube 444and the layer 72.

In FIG. 330, internal pressure 450 may be applied to the mandrel 440.The assembly may be placed in an oven, for example and cured at, forinstance, 130° C. for two hours. This may cause layer 72 to bond withthin walled tube 444. After this cure cycle, we may deflate and removemandrel 440 to free sheath 400.

FIG. 34 shows a partially formed tube 436 built over a solid mandrel(not shown). The solid mandrel may be, for instance, a metal bar insidethe partially formed sheath 436. The mandrel may be mounted to chuck 454which has chuck rotation 456. Reinforcement fiber 86 may be fed fromspool 244 which has spool rotation 254. By feeding spool 244 lengthwiseas chuck 454 rotates, a layer of reinforcement fiber 86 may be appliedto partially formed tube 436. Adhesive may be added to the reinforcementfiber. Additional layers may be laid on top of the reinforcement fiber86.

FIG. 35 illustrates that the partially formed sheath 436 can be placedin a vacuum bag. The vacuum bag may be formed of a top vacuum sheet 238a and a bottom vacuum sheet 238 b and vacuum seal tape 240. Air may beremoved from the bag via suction tube 242. The interior of the vacuumbag can be heated. The vacuum bag can be inserted inside of an oven orautoclave. The layers of the partially formed sheath 436 on the mandrelcan be thermally cured or melted, for example under from about 1 ATM toabout 30 ATM of pressure. The bag delivery channel can suction theinterior of the vacuum bag. For example the pressure in the vacuum bagcan be less than about 0.1 ATM.

A removable mandrel may be used in constructing a tube. The mandrel canbe formed of a low melting point wax or metal, a foam, some collapsingstructure, an inflatable bladder, a starch, a salt, a sugar, a PolyvinylAcetate or the like or combinations thereof. The mandrel may receive anoptional polymer coating that may form a wall. The wall can be less thanabout 0.001 in. thick. Laminates may be laid on the mandrel. Thelaminates may have adhesive applied to them. The mandrel and laminatesmay be placed in a vacuum bag. The vacuum bag may be placed at a lowpressure, for example zero pressure, such that the laminate iscompacted. The mandrel and laminates may have a section of heat shrinktubing placed around it. The mandrel and laminates may be consolidatedto create a tube. The mandrel may be removed, generally by placing thetube and mandrel at an elevated temperature or by some other way ofcollapsing the body of the mandrel.

Additional laminates can be added to areas of a tube that might requireextra strength for certain procedures or uses. A tube may have differentamounts of fiber, adhesive or polymer film in different portions of thetube wall. A tube may have different number of fiber layers in differentportions of the tube wall.

One or more laminates may be joined with adhesive. A polymer film may beplaced on the outside, the inside or both sides of the balloon. Apolymer may be sprayed brushed or coated onto the outside, the inside orboth sides of the balloon. One or more laminates can be consolidated toform a tube. The consolidation process may allow the laminate layers tocompact such that the ratio of fiber to adhesive in the tube walls afterconsolidation is greater than the ratio of fiber to adhesive in the tubewalls before consolidation. The laminates can be combined to producetubes with different mechanical properties.

A tube can have one or more laminates, adhesives, polymer films, orcombinations thereof. The laminates, and/or adhesive, and/or polymerfilms can be consolidated into each other to form part or all of a tube.The flexible adhesive may remain flexible when cured or melted. Thepolymer films or films may melt or set during consolidation. The tubemay be capable of sustaining pressure.

A very thin tube can be created via blow molding, rotational molding orsome other technique. The tube may have a wall thickness of less thanabout 0.001 in. and be made of a low compliance polymer such as PET orNylon. The tube may be a fiber reinforced tube. The tube may beinflated. Laminates may be laid on the surface of the tube. Thelaminates may have adhesive applied to them. The tube, together withsome laminates, may be placed in a female mold with the tube still underpressure. The pressure in the tube can be further increased to provideincreased force against the walls of the female mold. The laminates maybe consolidated to form a tube. The tube may merge or bond with thelaminates.

Method of Use

A tool 500 (which also can be referred to herein as a medical device)may be an endoscope, a laparoscope, a robotic surgical tool, a catheteror any other tool, instrument or device commonly inserted into the bodyas part of a medical procedure. The tool 500 may be flexible or rigid,or have portions which are flexible and portions which are rigid. Theflexible parts of the tool 500, if present, may be actuated by a drivemechanism such that the device can form different shapes during aprocedure. The actuation may be provided manually or by anelectromagnetic actuator or by the use of air or fluid pressure. The oneor more tools 500 can be non-robotic surgical tools, robotic surgicaltools or combinations thereof. The tool 500 may be used as part of anatural orifice transluminal endoscopic surgery (NOTES) procedure.

The tool 500 can be part or all of a (e.g., the da Vinci Surgical Systemfrom Intuitive Surgical, Inc., Sunnyvale, Calif.; Sensei or Artisan fromHansen Medical, Inc., Mountain View, Calif.: or robotic or motorizedcolonoscopy devices from Olympus Corporation, Japan, Pentax/HoyaCorporation, Japan).

FIG. 36 shows a portion of an articulating section 458 of a medicaldevice. The articulating section may be composed of one piece links 460that are rotatably attached to each other such that they form a pivot464. The pivot 464 may be formed by pressing two links, 460 a and 460 b,together. The pivot may be formed by passing a pin through both links.The medical device may have cables threaded thru holes 462. Pullingthese cables in combination or alone can induce a controlledarticulation of an articulating section 458 of a medical device.

FIG. 37 shows a portion of an articulating section 458 of a medicaldevice, a distal end piece 466 and proximal end piece 468. Distal endpiece 466 may include a camera, lighting, a surgical tool or tools, aballoon, or any other item commonly inserted into the body orcombinations thereof. Proximal end piece 468 may connect thearticulating section 458 to a larger medical instrument.

FIG. 38A shows a sheath 400 attached to a medical device 500.

FIGS. 38B, 38C and 38D shows a cross section of FIG. 38A. Articulatingsection 458 is shown enclosed within sheath 400. The radial clearance473 between the sheath and the medical device may be from about 0 inchesto about 0.25 inches, more narrowly from about 0 inches to about 0.05inches, yet more narrowly from about 0 inches to about 0.015 inches.

Seal 420 a has seal lip 470 a which may be in contact with the medicaldevice 500. Seal lip 470 a may grasp medical device 500 firmly such thatseal lip 470 a may not readily slide or may have a fit such that it canreadily slide. Seal 420 b has a seal lip 470B which may be in contactwith the medical device. Seal lip 470B may locate in groove 472 onmedical device 500. Seal lip 470B and groove 472 may restrain seal 420 bfrom longitudinal movement along the medical device 500. Groove 472 maybe a groove, notch, stop or visible marking. Groove 472 may be used as alocating feature for seals 420 a and 420 b. Seals 470 a and 470 b maysubstantially longitudinally fix the sheath with respect to the medicaldevice 500.

Seal lips 470 a and 470 b may prevent the passage of bodily fluids fromoutside the volume enclosed by the sheath 400 to inside the volumeenclosed by the sheath. Seal lips 470 a and 470 b may allow the volumeenclosed by the sheath 400 to be placed at a higher or lower pressurethan the pressure found in the volume outside that enclosed by thesheath. Placing the volume enclosed by the sheath at a differentpressure than the pressure surrounding the sheath and checking for leaksmay allow a surgeon to check if sheath 400 is leak-tight.

FIG. 38E shows that the articulating section 458 of medical device 500can easily flex while enclosed by sheath 400. At inside corner of thesheath bend 474, wrinkles may form on the sheath (not shown in thedrawing).

FIGS. 39A and 39B show a sheath 400 covering a portion of a medicaldevice 500. The medical device may be driven into a human body thru acannula 476 by control system 474 towards target 478 within the body apatient. Control system 474 may be operated by a human, may besemi-autonomous or autonomous. Control system 474 may be robotic ornon-robotic system. The robotic system can have actuation and a feedbackloop to control position, velocity or acceleration of some portion ofthe medical device 500.

FIG. 39A shows the medical device in a first position approaching thetarget 478.

FIG. 39B shows the medical device in a second position having reachedtarget 478. The longitudinal sheath length 412 in the first position canbe less than about 10% different (i.e., longer or short) than thelongitudinal sheath length 412 in the second position. The longitudinallength of the medical device covered by the sheath can change by lessthan 10% (i.e., longer or shorter) between the first and secondpositions. The distal and/or proximal ends of the sheath can be fixed ormove slightly (i.e., less than about 10% combined change in length, asstated above) or move significantly (i.e., more than about 10% combinedchange in length, as stated above) with respect to the tool 500. At theinside corner of the sheath bend 474, wrinkles may form on the sheath(not shown).

FIGS. 40A and 40B show a sheath 400 that could be placed over a medicaldevice 500. Sheath 400 has tube 402, endcap 422 and collar 480containing a seal. The distal end 466 of the medical device may be seenthru clear endcap 422 in FIG. 111 B: Endcap 422 may be clear, maycontain a lens or lenses, may have anti-reflection coatings, or may bedesigned to not obstruct certain wavelengths of light useful to aprocedure. FIG. 40C shows a medical device 500 being inserted intosheath 400.

FIGS. 41A and 41B show a portion of sheath 400 placed over a portion ofmedical device 500. The flexible medical device 500 has end 466 that isnot covered by the sheath but is substantially flush with the end of thesheath. FIG. 41A shows a portion of the flexible medical device in anapproximately straight configuration. FIG. 41B shows a portion of themedical device in an approximately right angle configuration. At insidecorner of the sheath bend 474, wrinkles may form on the sheath (notshown in the drawing). During the course of operation of the medicaldevice, the sheath may get pinched or crimped by the motion of themedical device. For instance, the sheath may be caught between links 460of the medical device. The design of the sheath may allow the sheath toresist puncture during pinching, crimping or catching derived from themedical device or by devices surrounding the outside of the sheath.

FIG. 42 shows a portion of sheath 400 placed over a portion of medicaldevice 500. Medical device 500 has distal tip 466. Medical device 500has an articulating section 458 near its tip 466. The distal end ofsheath 500 is located proximal to articulating section 458.

FIG. 43 shows medical device 500 with circular groove or other sheargeometry 486 on the distal end of the-medical device. A portion 400 of asheath is shown. The portion 400 of the sheath has a fitting on thedistal end with a slot 482. Clip 484 is shown before being inserted

FIGS. 44A and 44B show the connection of medical device 500 and sheathportion 400. Clip 484 fits into both slot 482 and slot 486 to secure themedical device 500 to sheath portion 400. Boss 488 serves to reinforcedclip 484.

FIG. 44C shows a cross section of FIG. 44B.

Multiple sheaths may be used over one medical device: The sheaths couldbe placed at different points along the longitudinal axis of the medicaldevice such that the sheaths do not overlap.

One sheath could be placed over a second sheath, both sheaths coveringthe medical device. One sheath could be disposed of after fewerprocedures than the second sheath.

The sheath may be permanently attached to the medical device. The sheathmay only extend over sections of the medical device that can bearticulated.

Sheath 400 may be affixed to a medical device during the manufacture ofthe medical device. Sheath 400 may be affixed to the medical device by amedical professional before use in a procedure. A sheath may be usedduring a single procedure and then disposed of. A sheath may be used fort or more procedures and then disposed of A sheath may be a permanentpart of a medical device. A sheath may he cleaned after each procedure.

The sheath may need to resist puncture during the medical procedureemploying the medical device. The sheath may be punctured by structuresin the body, such as bone. The sheath may be punctured by the motion ofthe medical device against the sheath. The medical device may be aflexible structure. The medical device may contain discrete joints thatcan pinch the sheath.

Tubes may need to be packed to the smallest possible size when enteringand exiting the body. Pleating or fluting the tube walls is typical.Pleating may be accomplished by placing the tube into a mechanicalfixture and then heating the tube to approximately 80° C. for 1 minute.The heat will cause the tube to reflect the geometry of the mechanicalfixture.

The sheath may need to resist puncture while exposed to extreme coldduring, for instance, a medical procedure involving a cryogenic liquid.

A sheath may include a tube. A sheath can be a sleeve, a drape, acovering, a blood barrier or a biological barrier.

The sheath may need to be made and sold for a low cost.

The sheath may need to be flexible enough to not significantly interferewith the function of the medical device.

It will be appreciated by those skilled in the art having the benefit ofthis disclosure that this invention provides a fiber reinforced sheath.It should be understood that the drawings and detailed descriptionherein are to be regarded in an illustrative rather than a restrictivemanner, and are not intended to limit the invention to the particularforms and examples disclosed. On the contrary, the invention includesany further modifications, changes, rearrangements, combinations,substitutions, alternatives, design choices, and embodiments apparent tothose of ordinary skill in the art, without departing from the spiritand scope of this invention.

We claim:
 1. A device for therapeutic and/or diagnostic use in or on apatient's body comprising: a sheath comprising a laminate comprisingreinforcement fibers, wherein the laminate has a thickness from about 25μm to about 500 μm and a tensile strength of greater than about 138 MPa;and a tool at least partially within the sheath and is attached to thesheath, wherein the tool comprises a bending portion within the sheath,the bending portion configured to bend from a first position to a secondposition; and wherein the sheath has a sheath length measured from adistal end of the sheath to a proximal end of the sheath, and whereinthe sheath length when the tool is in the first position issubstantially equal to the sheath length when the tool is in the secondposition.
 2. The device of claim 1, wherein the sheath further comprisesa reinforcement member, wherein the reinforcement member is more rigidthan the laminate.
 3. The device of claim 2, wherein the reinforcementmember is substantially helical.
 4. The device of claim 1, wherein thetool is releasably attached to the sheath.
 5. The device of claim 1,further comprising a robotic system for therapeutic and/or diagnosticuse.
 6. The device of claim 5, wherein the tool is part of or attachedto the robotic system.
 7. The device of claim 1, wherein the sheath hasa fluid-tight seal to the tool.
 8. The device of claim 1, wherein thesheath has a dielectric strength greater than 1000 volts per 0.001inches.
 9. The device of claim 1, wherein the sheath has a failurestrain of less than 0.30.
 10. The device of claim 1, wherein the bendingportion comprises an articulating section.
 11. The device of claim 1,wherein the bending portion comprises a pivoting section.
 12. The deviceof claim 1, wherein the sheath has a tensile strength of greater thanabout 276 MPa.
 13. The device of claim 1, wherein the sheath has atensile strength of greater than about 414 MPa.
 14. A device fortherapeutic and/or diagnostic use in or on a patient's body comprising:a sheath comprising a laminate comprising reinforcement fibers whereinthe laminate has a failure strain of less than 0.30; and a tool at leastpartially within the sheath, wherein the tool is fixedly attached to thesheath, and wherein the tool has a sheathed tool length measured alongthe length of tool within the sheath, and wherein the tool comprises abending portion within the sheath, the bending portion configured tobend from a first position to a second position, wherein the sheathedtool length in the first position is less than about 10% different thanthe sheathed tool length in the second position.
 15. The device of claim14, wherein the sheath further comprises a reinforcement member, whereinthe reinforcement member is more rigid than the laminate.
 16. The deviceof claim 14, wherein the sheath has a tensile strength of greater thanabout 138 MPa.
 17. The device of claim 14, wherein the sheath has afailure strain of less than 0.20.
 18. The device of claim 14, whereinthe sheath has a failure strain of less than 0.10.
 19. The device ofclaim 14, wherein the sheath has a failure strain of less than 0.05. 20.A device for therapeutic and/or diagnostic use in or on a patient's bodycomprising: a sheath comprising a laminate including reinforcementfibers and a reinforcement member wherein the reinforcement member ismore rigid than the laminate; and a tool releasably attached to thesheath, wherein the sheath has an unsupported burst pressure of greaterthan about 150 psi.